Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for
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(2020) 20:602
STUDY PROTOCOL
Open Access
Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery Philippe Deruelle1,2* , Sophie Lelorain3, Sylvie Deghilage1, Emmanuelle Couturier1, Elodie Guilbert1, Paul Berveiller4, Marie Victoire Sénat5, Christophe Vayssière6, Loïc Sentilhes7, Franck Perrotin8, Denis Gallot9,10, Céline Chauleur11, Nicolas Sananes2,12, Emmanuel Roth2, Dominique Luton13, Marie Caputo14, Elodie Lorio15, Carla Chatelet16, Julien Couster17, Oumar Timbely18, Muriel Doret-Dion19, Alain Duhamel20 and Marie Pigeyre21
Abstract Background: Pre-pregnancy obesity and excessive gestational weight gain (GWG) are established risk factors for adverse pregnancy, delivery and birth outcomes. Pregnancy is an ideal moment for nutritional interventions in order to establish healthier lifestyle behaviors in women at high risk of obstetric and neonatal complications. Methods: Electronic-Personalized Program for Obesity during Pregnancy to Improve Delivery (ePPOP-ID) is an open multicenter randomized controlled trial which will assess the efficacy of an e-health web-based platform offering a personalized lifestyle program to obese pregnant women in order to reduce the rate of labor procedures and delivery interventions in comparison to standard care. A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum. The intervention is based on nutrition, eating behavior, physical activity, motivation and well-being advices in which personalization is central, as well as the use of a mobile/tablet application. Inputs includes data from the medical record of participants (medical history, anthropometric data), from the web platform (questionnaires on dietary habits, eating behavior, physical activity and motivation in both groups), and adherence to the program (time of connection for the intervention group only). Data are collected at inclusion, 32 weeks, delivery and 10 weeks postpartum. As primary outcome, we will use a composite endpoint score of obstetrical interventions during labor and delivery, defined as caesarean section and instrumental delivery (forceps and vacuum extractor). (Continued on next page)
* Correspondence: [email protected] 1 Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000 Lille, France 2 Pôle Gynécologie, Obstétrique et Fertilité, Hôpitaux Universitaires de Strasbourg, 67200 Strasbourg cedex, France Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and i
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